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NCT Number: NCT07550114

PVI vs ESP Block for Reducing Bleeding and Postoperative Pain in Lumbar Fusion Surgery.

This randomized controlled trial compares periarticular vasoconstrictor infiltration (PVI) versus erector spinae plane block (ESP) to reduce bleeding and postoperative pain in adults undergoing lumbar fusion surgery (up to 3 levels). Patients are randomly assigned 1:1 to receive ultrasound-guided ropivacaine 0.2% + epinephrine 1:200,000: PVI (150-200mL bilateral in retrolaminar, thoracolumbar fascia, supraspinous ligament, subcutaneous planes) or ESP (20mL/side at transverse processes). Both groups receive standardized general anesthesia (TIVA), multimodal analgesia (dexamethasone, paracetamol, dexketoprofen/metamizole, ketamine, magnesium), and tranexamic acid. Multicenter study: Hospital de la Santa Creu i Sant Pau (Barcelona, 32 patients) and Hospital Quirón Salud Murcia (30 patients). Primary outcome: intraoperative blood loss (surgical aspirate minus irrigation + gravimetric gauze weight). Secondary outcomes: Fromme surgical field scale, pain (NRS at REA discharge/24h/48h), opioid consumption (morphine equivalents), PONV/antiemetic use, drain output, hospital stay, patient satisfaction. N=62 patients (31/arm). Blinded outcome assessment.

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Key information

Conditions

Surgical Blood Loss Blood Loss, Surgical Hemorrhage Intraoperative Complications Lumbar Spinal Fusion Surgery Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

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About this study

Lumbar fusion surgery treats degenerative disc disease, spondylolisthesis, and lumbar stenosis but carries high intraoperative bleeding risk (500-2000mL loss, 30% transfusion rate) and severe postoperative pain requiring systemic opioids. Periarticular vasoconstrictor infiltration (PVI), based on tumescent/WALANT principles, shows promise for hemostasis and analgesia by creating chemical tourniquet via epinephrine while blocking dorsal rami. Erector spinae plane (ESP) block is current standard but uses lower volumes (20mL/side) and different anatomic target. No prior RCTs compare PVI vs ESP head-to-head in lumbar fusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • More than 18 years old.
  • ASA I-III
  • Scheduled primary spinal instrumentation surgery (lumbar/thoracolumbar fusion)
  • Signed informed consent

Exclusion criteria

  • Allergy/contraindication to study drugs (ropivacaine, epinephrine)
  • Coagulopathy.
  • Infection at block site
  • Neuromuscular disease affecting evaluation.
  • Chronic opioid use (>30mg morphine equivalents/day)
  • Cognitive impairment preventing pain reporting.
  • Pregnancy

Treatment and study plan

Periarticular vasoconstrictor infiltration (PVI)

Procedure

Periarticular Vasoconstrictor Infiltration (PVI) vs ESP Block: Multi-level infiltration technique (4 planes: retrolaminar, thoracolumbar fascia, supraspinous ligament, subcutaneous) vs single interfascial injection. High-volume (150-200mL bilateral, 20mL/vertebra) vs low-volume (40mL total). Multiple punctures (4-6 levels) vs single-level per side. Paravertebral chemical sympathectomy vs somatic nerve blockade. Targets surgical field bleeding control + analgesia vs thoracic dermatomal analgesia only.

erector spinae block (ESP)

Procedure

Erector Spinae Plane Block (ESP) vs PVI Infiltration: Single interfascial injection vs multi-level infiltration. Low-volume (20mL/side, 40mL total) vs high-volume (150-200mL). Single puncture per side at transverse processes vs multiple punctures (4-6 levels). Tip positioned above transverse process targeting erector spinae interfascial plane vs 4 anatomical planes (retrolaminar, fascia, ligament, subcutaneous). Somatic nerve blockade (thoracic dermatomes) vs paravertebral chemical sympathectomy + analgesia.

Primary outcomes

  1. Total Surgical Bleeding

    Time frame: Day 0

    Total blood loss measured by aspiration from surgical field + weighed gauzes (after subtracting irrigation fluid volume)

Secondary outcomes

  1. Postoperative Pain (NRS)

    Time frame: Day 1, day 2

    Numeric Rating Scale (0-10) for pain intensity

  2. Opioid Consumption

    Time frame: Day 1, Day 2

    Total morphine equivalents (rescue doses) in first 48h

  3. Fromme Surgical Field Grade

    Time frame: Day 0

    Surgical field bleeding quality (Grade 0-4)

  4. Length of Hospital Stay

    Time frame: Perioperative

    Days from surgery to hospital discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Mireia MD, PhD Rodriguez Prieto, Anesthesiologist

CONTACT

[email protected]

677896054

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Registry information

Official study title

EFFICACY OF PERIARTICULAR VASOCONSTRICTOR INFILTRATION (PVI) VERSUS ERECTOR SPINAE PLANE BLOCK (ESP) IN REDUCING BLEEDING AND POSTOPERATIVE PAIN CONTROL IN LUMBAR FUSION SURGERY: RANDOMIZED CLINICAL TRIAL.

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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